Principal K.M. Kundnani College of Pharmacy established Department of Pharmaceutical Analysis for the first time in India in 1992, realizing the importance of the subject to the Pharmaceutical and Allied Industry. The permission for the same was granted by AICTE in 1995 which was subsequently ratified by University of Mumbai.

Teaching Programme :

For the undergraduates, Pharmaceutical Analysis is taught from 2nd year onwards along with practicals. As Pharmaceutical Analysis requires analytical instruments, the students are taught extensively the analytical methods and techniques including the application of sophisticated instruments like GC, HPLC, spectroscopic methods like NMR, GC-MS, LC-MS etc. for drugs, pharmaceuticals and others.

Dr.(Mrs.) P.D. Hamrapurkar is recognized as a research guide for Ph.D.(Tech) and the Pharmaceutical Analysis laboratory is recognized for conducting Ph.D. programmes in Pharmaceutical Analysis by the University of Mumbai.

The postgraduate laboratory for Pharmaceutical Analysis is equipped with latest analytical state-of-the-art equipments and trained analyst to undertake pharmaceutical analysis, drug analysis from the biological fluids and herbal formulations. The major research programmes are largely focused on new analytical method development.

Postgraduates have core subjects like Advanced Pharmaceutical Analysis, Quality Assurance and they are specifically trained in Bioanalytical methods, GLP and documentation systems.

Research Focus:

Pharmaceutical Analysis like the other fields is in a state of flux. Modern Analytical Chemistry, despite its apparent multidisciplinary character, is a unified and independent scientific discipline which participates with other sciences in optimization and development of many processes in the modern technology. Analysis of pharmaceuticals are faced with ever increasing demand for more sensitive and specific methods to detect the increasing number of clinical agents.

Today, modern pharmaceutical analysis entails good understanding of the physicochemical behavior of solids to ensure a better selection of formulation. Identification of process related impurities allows prevention of occurrence of these impurities and degradation products. The analytical procedures for impurity profiling should be validated and suitable for detection and quantitation of impurities. Furthermore data generated must comply all regulatory requirements.

Keeping all these different needs and importance of analytical methodology, the experiments are performed to standardize and then obtain a procedure capable of qualifying or quantifying a given substance. While developing analytical methodologies, we validate the method by determining important paradigms viz., potency, stability, purity and others. Thus we define the control system and then suitable and appropriate control parameters and techniques are selected for method development. We have developed new analytical assay techniques for drugs like Rofecoxib, Sildenafil, Clarithromycin, Oxcarbamazepine, Soy Isoflavone (daidzein), Glucosamine, Zaleplon, Pitavastatin and others.

Problems related to bioavailability, bioequivalence, new drug development, drug abuse, clinical pharmacokinetics and drug research are highly dependent on bio-pharmaceutic analytical methodology. Among these, bioanalysis plays a special pivotal role in pharmacokinetics, bioavailability and bioequivalence studies. With the use of newer analytical techniques.

Principal K.M. Kundnani College of Pharmacy’s Bioequivalence/Bioavailability Centre is involved in Clinical Research (Phase I) studies of new drug molecules and their estimation in human plasma for various pharmaceutical industries.

The Pharmaceutical Analysis laboratory is closely associated with the bioanalysis of blood / plasma / serum for determining drug levels in human beings. Such analysis are carried out by standardization, optimization and validation, keeping all the quality control requirements. The bioanalytical laboratory functions are to provide accurate and reliable data as rapidly as possible at low cost on wide variety of samples.

Analytical services to Industry :

The Pharmaceutical Analysis laboratory also conducts analysis like Osmolality Testing for ophthalmic solutions, snake venom antiserum, parenterals; Particle Size Analysis of technical bulk drugs, Differential Scanning Calorimeter (DSC) in thermal analysis; surface tension and viscosity measurements for various pharmaceutical and allied industries including research institutions.

Postgraduate students research activities of Department of Pharmaceutical Analysis are focused on

1. Herbal standardization by identifying biomarkers.
2. Analytical method development
3. Impurity profile studies of some known drugs

Till date 30 students have completed their post graduation from the Department of Pharmaceutical Analysis. Number of papers presented from the department is 47 and number of papers published : National 13 and International 6.

Faculty members:

Dr. (Mrs.) P.D. Hamrapurkar - Asst. Prof. & I/c.Head of Department of Pharmaceutical Analysis